眾生藥業(002317.SZ):一類創新藥ZSP1601片Ⅱb期臨牀試驗完成首例受試者入組
格隆匯6月4日丨眾生藥業(002317.SZ)公佈,近日,公司控股子公司廣東眾生睿創生物科技有限公司(“眾生睿創”)組織開展的用於治療非酒精性脂肪性肝炎(NASH)的一類創新藥物ZSP1601片Ⅱb期臨牀試驗完成首例受試者入組。
目前眾生睿創已完成在健康受試者的Ia期和在NASH患者的Ib/Ⅱa期臨牀試驗,ZSP1601片在這兩項研究中表示出良好的安全性和耐受性。在Ib/Ⅱa期臨牀試驗中,ZSP1601片治療4周可改善NASH患者的肝臟炎症和損傷的相關生物標誌物如丙氨酸氨基轉移酶(ALT)、門冬氨酸氨基轉移酶(AST),肝臟脂肪含量指標(PDFF)和纖維化指標等,且具有明顯的量效關係,與安慰劑組相比有顯著統計學差異。上述結果為ZSP1601片治療NASH的進一步臨牀試驗提供支持。
ZSP1601片是具有全新作用機制和全球自主知識產權的用於治療NASH的化學一類創新藥物,屬於First-in-class藥物,為境內首個進入臨牀試驗用於治療NASH的創新藥物,如未來成功上市,將填補我國NASH治療領域目前無藥可用的空白。
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